Functional Training for the Prevention of Deep Venous Thrombosis

NCT03740633 | Unknown Phase 3 DMC

• 1 other identifier: GO-FUN
• Study Type: interventional
• Target: 398
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to analyze the post-operative functional training on the prevention of deep venous thrombosis (DVT) in the patients who have accepted major surgeries for the gynecological malignancies. The functional training consists of: (1) active and passive ankle pump motions including flexion and extension, circumduction; (2) abdominal breathing training. The primary end is the incidence of DVT happened 30 days from surgery. The secondary ends include the patients satisfaction about functional training.

Conditions

Ankle Motion; Gynecologic Neoplasm; Deep Venous Thrombosis; Abdominal Breathing

Outcome Measures

Primary Outcomes (1)

• deep venous thrombosis

  incidence of deep venous thrombosis

  One years

Secondary Outcomes (2)

• adverse events

  One year

• patient satisfaction

  One year

Study Arms (2)

Study group

EXPERIMENTAL

Patients in the study group accept functional training and regular care.

Behavioral: passive ankle pump motions on the day of surgery; Behavioral: active ankle pump motions and abdominal breathing training on the 1-3 day after the surgery; Combination Product: Regular care

Control group

ACTIVE COMPARATOR

Patients in the control group only accept regular care.

Combination Product: Regular care

Interventions

passive ankle pump motions on the day of surgery BEHAVIORAL

Passive ankle pump motions include flexion and extension, circumduction, which will be conducted by caregiver on the day of surgery.

Study group

active ankle pump motions and abdominal breathing training on the 1-3 day after the surgery BEHAVIORAL

Active ankle pump motions include flexion and extension, circumduction, which will be conducted by patient on the 1-3 day after the surgery. On the same time, the patient is given abdominal breathing training.

Study group

Regular care COMBINATION_PRODUCT

Regular post-operative care consists of compression stockings, anticoagulant and instructions of early mobilization

Control group; Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having received major surgeries for gynecologic malignancies
• Good performance status
• Aged 18 years or older
• Signed an approved informed consents
• No injuries to the skin, musculoskeletal system
• No venous thromboembolic disease before surgeries

You may not qualify if:

• Delayed extubation

Sponsors & Collaborators

• Lei Li: lead

Study Sites (1)

Lei Li

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Genital Neoplasms, Female; Venous Thrombosis

Condition Hierarchy (Ancestors)

Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Lei Li, M.D.

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lei Li, M.D.

CONTACT

+8613911988831; lileigh@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 10, 2018
• First Posted: November 14, 2018
• Study Start: November 10, 2018
• Primary Completion: November 10, 2019
• Study Completion: November 10, 2019
• Last Updated: November 14, 2018

Record last verified: 2018-11

Locations

CN (1)